Nexavar Dosing in Renal Cancer Patients in "Real-life" Setting

This study is a registry of renal cancer patients treated with Nexavar. It aims to evaluate the actual dosing of Nexavar in "real-life" setting vs. the prescribed dose.

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Key information

Conditions

Carcinoma, Renal Cell Adenocarcinoma Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Urogenital Diseases Urogenital Neoplasms Urologic Diseases Urologic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >/= 18 years
Diagnosis of renal cell carcinoma
Failure of prior therapy with interferon-alfa (IFN) or interleukine-2 (IL-2) or disqualified from therapy with IFN/IL-2
Patients in whom the oncologist has decide to start therapy with sorafenib.

Exclusion criteria

Synonymous with contraindications to Nexavar.

Treatment and study plan

Sorafenib (Nexavar, BAY43-9006)

Drug

Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)

Primary outcomes

Percentage of patients in whom the actual dose of sorafenib equaled the planned dose

Time frame: 12 months

Secondary outcomes

Overall tolerability of treatment as measured by rate of adverse events

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Nexavar Dose Evaluation Study in Patients With Advanced Renal Cell Carcinoma

Acronym: NEXST

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2016
First posted: Mar 19, 2012
Registry last updated: Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed